A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)
A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003)
Sponsor: Merck Sharp & Dohme LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of participants who experienced dose-limiting toxicities (DLTs) in Part 1
Time frame: Up to ~6 weeks
Number of participants who experienced an adverse event (AE)
Time frame: Up to ~68 months
Number of participants who discontinued study treatment due to an AE
Time frame: Up to ~68 months
Overall survival (OS)
Time frame: Up to ~35 months
Secondary Endpoints
Objective response rate (ORR)
Duration of response (DOR)
Eligibility Criteria
Inclusion Criteria: * Has a histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL). * Has radiographically measurable DLBCL per the Lugano Response Criteria, as assessed locally by the investigator. * Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment initiation. * Has adequate organ function. * Is able to provide new or archival tumor tissue sample not previously irradiated. Zilovertamab vedotin plus R-GemOx, or R-GemOx study arms: * Has relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least 1 line of prior therapy. * Has post-chimeric antigen receptor T (post-CAR-T) cell therapy failure or is ineligible for CAR-T cell therapy. Not applicable with protocol amendment 4: Zilovertamab vedotin plus Bendamustine Rituximab (BR), and Bendamustine Rituximab study arms: * Has relapsed or refractory DLBCL and is ineligible for or …
Read full criteria on CT.gov →✦ Analyst Commentary
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